A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers

A Phase 1, Randomized, Double-Blind, Two-arm, Parallel Design, Comparative Study to Assess Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® Following a Single Dose of 600 mg Subcutaneous Injection in Healthy Male Volunteers

This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers.

Study Overview

• Status: Recruiting
• Conditions: Healthy Male Participants
• Intervention / Treatment: Biological: Herceptin Hylecta®; Biological: Bmab3000

Detailed Description

This is a Phase 1, randomized, double-blind, two-arm, parallel-group trial comparing the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose.

A total of 150 healthy male participants (75 per arm) will be enrolled to ensure 138 evaluable subjects. Participants will be randomized in 1:1 using stratified block randomization based on baseline body weight (≥50-≤75 kg and >75-≤100 kg).

Each participant will be involved in the study for approximately four months, which includes one screening visit, a 3-night inpatient stay, and 16 scheduled outpatient follow-up visits. Participants will attend a screening visit (Day -28 to Day -1) to confirm eligibility. This will include obtaining informed consent, medical history, physical examination, vital signs, biometric measurements, ECG, echocardiogram, and blood and urine tests, as well as drug and alcohol screening. Eligible participants will be admitted to the study site on Day -1 for pre-dose assessments to confirm continued eligibility. On Day 1, participants will receive a single subcutaneous injection of either Bmab3000 or Herceptin Hylecta. During the inpatient stay (Days -1 to 3), participants will undergo continuous safety monitoring, including regular vital signs, ECGs, injection site checks, and blood sampling for pharmacokinetic, safety, and immunogenicity assessments. After discharge, participants will return for outpatient visits till Day 85 for continued safety monitoring, blood sampling for pharmacokinetic and immunogenicity analyses, and ECGs and vital sign assessments. The final visit on Day 91 will include a full physical examination, echocardiogram, ECG and blood sampling for pharmacokinetic & immunogenicity analyses and final laboratory evaluations.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dr Gursharan Singh, MBBS, PhD; Phone Number: 9650628534; Email: gursharan.singh@biocon.com
• Study Contact Backup: Name: Rajesh CN; Phone Number: +919725466994; Email: rajesh.cn@biocon.com

Study Locations

• New Zealand
  • Main Building: 264 Antigua Street,
    • Christchurch, Main Building: 264 Antigua Street,, New Zealand
      • Recruiting
      • New Zealand Clinical Research (NZCR)
      • Contact: Cory Sellwood, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male volunteers aged between 18 to 65 years; both inclusive.
2. Body weight ≥50 kg and ≤100 kg with body mass index (BMI) between 18.5 and 30 kg/m2, both inclusive.
3. Participants should have Left ventricular ejection fraction (LVEF) ≥55%.
4. Male participants must be using an acceptable method of contraception for the entire duration of the trial, and for at least three months after the trial drug administration. Participants must refrain from fathering a child or donating sperm in the next three months following the last trial drug administration or undergoing vasectomy.
5. All non-prescription medications must have been discontinued at least 14 days prior to dosing.
6. All non-topical prescription medications must have been stopped at least 30 days prior to admission to the clinical research center.
7. Absence of significant findings in the vital signs, 12 lead ECG, and clinical laboratory tests of blood and urine.
8. Willing and able to sign the informed consent form (ICF).

Exclusion Criteria:

1. History of previous exposure to trastuzumab.
2. Presence of clinically significant medical history and clinically significant findings in the physical examination.
3. Allergy or hypersensitivity to trastuzumab, other recombinant human or humanized antibodies, other related products, or any excipients/ ingredients (e.g. hyaluronidase).
4. Sick sinus syndrome or known long QT syndrome (QTcF >450 msec).
5. Pronounced sinus bradycardia (<40 bpm), even if elicited by sport.
6. History of relevant drug and/or food allergies.
7. Positive urine drug and breath alcohol screen.
8. Consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening/admission to the clinical research center.
9. Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
10. Donation or loss of blood prior to drug administration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bmab3000; Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL	Biological: Herceptin Hylecta®; Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL
Active Comparator: Herceptin Hylecta®; Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL	Biological: Bmab3000; Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum observed concentration (Cmax) of drug Bmab 3000	Day 1 to Day 91
AUCo-∞	Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf)	Day 1 to Day 91

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCo-t	Area Under the serum Concentration versus time curve from time 0 to the last sampling time at which concentrations were at or above the limit of quantification	Day 1 to Day 91
Tmax	Time to maximum observed concentration	Day 1 to Day 91
Vd/F	Volume of distribution	Day 1 to Day 91
Cl/F	drug clearance	Day 1 to Day 91
t1/2	Apparent terminal elimination half-life	Day 1 to Day 91
AUC% extrapolation	% of the AUC that has been derived after extrapolation	Day 1 to Day 91
λz	Elimination rate constant	Day 1 to Day 91

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety_ Adverse Reactions	Adverse Events and Adverse Reactions during the Treatment Period	Baseline to Day 91
Safety_ Injection-site Reactions	Injection-site Reactions	Day 1 to Day 91
Immunogenicity	Developing Antidrug Antibodies	Day 1 to Day 91
Immunogenicity	Developing Neutralizing Antibodies	Day 1 to Day 91

Collaborators and Investigators

• Sponsor: Biocon Biologics UK PLC
• Investigators: Principal Investigator: Dr Cory Sellwood, MBBS, New Zealand Clinical Research (NZCR) Main Building: 264 Antigua Street, Christchurch, New Zealand; Principal Investigator: Dr Leanne Barnett, MBBS, New Zealand Clinical Research (NZCR) Main Building: 3 Ferncroft Street, Grafton, Auckland, New Zealand

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BIO-TRASTU-103; U1111-1329-7865 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No